跳至主要内容
临床试验/NCT05839158
NCT05839158已完成不适用

Evaluation of the Efficacy of Follicles-derived Microtissue Homogenate in Promoting Wound Healing After Hair Transplantation

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Changes in the area of the wound at the donor site

研究概览

简要总结

Autologous hair transplantation involves follicle extraction, trimming, and implantation. Follicle trimming improves efficiency and postoperative appearance, resulting in the discarded tissue known as hair follicle-derived microtissue (HFMT). In a clinical case, HFMT homogenate was applied to the FUE donor area wound, resulting in reduced pain, relief from itching, and faster healing compared to conventional treatment. This study aims to compare the effects of HFMT on FUE donor area wound healing.

详细描述

The process of autologous hair transplantation involves three steps: FUE follicle extraction, follicle trimming, and follicle implantation. The purpose of follicle trimming is to improve the efficiency of follicle implantation and enhance the immediate postoperative aesthetic appearance. Therefore, during the follicle trimming process, the sebaceous glands and above-mentioned epidermis, partial dermis tissue, and surrounding tissue of the follicles are usually separated and discarded, and the remaining follicle tissue is implanted into the recipient area. The investigator collectively refers to the discarded tissue as hair follicle-derived microtissue (HFMT). In a clinical case, The investigator accidentally discovered that if the HFMT obtained from the follicular unit extraction (FUE) method was collected, cut into pieces, and made into tissue homogenate, and then the HFMT homogenate was used to cover the FUE donor area wound, the patient reported reduced postoperative pain and some relief from skin itching. Additionally, compared to conventionally treated wounds, the wound in the donor area healed faster. Based on these findings, this study aims to compare the effects of HFMT on the healing of FUE donor area wounds.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-60 years who underwent FUE autologous hair transplantation.
  • The patient's liver and kidney function were normal, and the serum protein level before surgery was normal.

排除标准

  • Patients with a history of smoking.
  • Those suffering from diseases that affect wound healing, such as diabetes or hyperglycemia.
  • Those with abnormal blood sugar.
  • Abnormal cardiopulmonary function.
  • There are foci of infection in or near the surgical area.
  • Scar hyperplasia or scar constitution.
  • Those with a history of neuralgia.
  • The patient took immunosuppressants, cytostatics, and hormonal anticoagulants before surgery and antibiotics.

结局指标

主要结局

Changes in the area of the wound at the donor site

时间窗: post op days 3, 5, 7, 14 and post op weeks 4, 6, 8, 12, 16, 24

Using a dermatoscope, randomly select 3 fields of view, measure the area of all wounds in the field of view, and calculate the average value of the deviation between the wound area and the initial wound area.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验